Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents
2016年5月12日 更新者：University of California, San Francisco
Using Multimedia Digital Health to Enable and Engage Pediatric Inpatients and Their Parents: A Pilot Study
This project leverages digital health technology to support patient engagement and shared decision-making between families, patients, and providers.
The investigators will start by finalizing the educational module and adding randomization for the trial (Aim 1).
The investigators will then complete iterative user testing in the live system through measurement of educational module views and usability feedback interviews with 20 end users (Aim 2).
The investigators will then conduct a randomized controlled trial to test the impact of the educational module on existing measures of patient engagement (Aim 3).
The hypothesis is that parents who receive the educational module will have higher scores on shared decision-making, patient activation and overall patient experience.
研究概览
地位
完全的
详细说明
Hospitals are not consistently patient centered, contributing to worse outcomes and a sense of loss of control.
Prior interventions that promote patient-centered care focused on provider and hospital factors vs. engaging patients directly.
No project to date has capitalized on digital health technology to engage families in shared decision-making and patient engagement.
The goal of the proposed randomized controlled trial is to test the impact of an evidence-based educational module delivered using an interactive patient-facing IT platform, on measures of patient engagement and shared decision-making.
The platform was developed for the UCSF Benioff Children's Hospital by OneView, Inc. and includes an educational module that promotes shared decision-making through orientation to the hospital and evidence-based teaching on engaging with providers.
This study will provide pilot data for a large-scale trial measuring the impact of the system on patient engagement.
The investigators will start by finalizing the educational module and adding randomization for the trial (Aim 1).
The investigators will then complete iterative user testing in the live system through measurement of educational module views and usability feedback interviews with 20 end users (Aim 2).
The investigators will then conduct a randomized controlled trial to test the impact of the educational module on existing measures of patient engagement (Aim 3).
Our hypothesis is that parents who receive the educational module will have higher scores on shared decision-making, patient activation and overall patient experience.
The eligible study population is all pediatric and newborn inpatients and their caregivers from June 2015 - August 2015.
The investigators anticipate needing a sample size of 100, 50 in each arm.
This pilot will generate key information on the platform's feasibility and acceptability and initial data on effect sizes to power future large-scale grants.
研究类型
介入性
注册 (实际的)
58
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 95年 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- An admitted patient (up to age 22) or caregiver (up to 95) of an admitted patient at Benioff Children's Hospital in the acute care units, the pediatric hematology-oncology units, or the transitional care units, admitted to the hospital within the past 72 hours.
Exclusion Criteria:
- Was already admitted and discharged during the study period.
- Not an English speaker.
- Not having a parent or legal guardian present or available by phone to give consent for those <18 years of age.
- Patient is in foster care.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Treatment
Empower educational module: After the patient activation measure/s are collected, for parents or patients assigned to the intervention arm, they will be given an opportunity to launch the EMPOWER video and interactive powerpoint.
They will be able to pause on reviewing the educational material and come back to it, as with other assigned education, and they will be able to review it again if they would like.
Discharge surveys will be assigned 24 hours prior to the estimated discharge time in Apex.
Oneview will display notifications that the surveys have been assigned.
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Evidence-based video module delivering content of the Right Question intervention from Deen et al. (2011)
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无干预：Control
Standard care: Those who opt to participate in the study will be randomly assigned to receive standard features of the media center (control group), or standard features plus the educational module intervention.
They will complete online (1) a baseline patient activation survey (for patients old enough to complete and for caregivers) at the start of their participation, and (2) an end-of-study survey pre-discharge or at the end of the study period.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change in activation as measured with the Parent Patient Activation Measure (PPAM)
大体时间：Measured at enrollment, and at hospital discharge--duration of hospital stay is an average of 3 days. Calculated as change in PPAM scores.
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Measured at enrollment, and at hospital discharge--duration of hospital stay is an average of 3 days. Calculated as change in PPAM scores.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Shared Decision-Making measured using the CollaboRATE 3-item scale
大体时间：Measured at discharge, an average of 3 days after study enrollment
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Measured at discharge, an average of 3 days after study enrollment
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Quality of Shared Decision-Making measured using M-PICS scores
大体时间：Measured at discharge, an average of 3 days after study enrollment
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Measured at discharge, an average of 3 days after study enrollment
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Length of Stay obtained from the Epic electronic health record
大体时间：Measured at discharge, an average of 3 days after study enrollment
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Measured at discharge, an average of 3 days after study enrollment
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30-day readmission obtained from the Epic electronic health record
大体时间：Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment
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This is a binary measure assessing whether the patient was readmitted to the hospital (Benioff Children' Hospital) within 30 days after discharge date.
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Measured 30 days after discharge. Discharge occurs an average of 3 days after study enrollment
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Study Recruitment Rate
大体时间：Baseline
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Number of patients with at least one person agreeing to participate (either a family member or a child) / Number of eligible patients who were assigned the study introduction materials in the hospital electronic educational center
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Baseline
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Study Retention
大体时间：Measured at discharge, an average of 3 days after study enrollment
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Number of participants who complete the survey capturing the second patient activation measure prior to hospital discharge / Number of participants who completed the first Patient Activation Measure
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Measured at discharge, an average of 3 days after study enrollment
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Engagement with the Educational Module
大体时间：Duration of the hospital stay, an average of 3 days
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Number of participants viewing the EMPOWER educational module (intervention) at least once / Number of patients assigned the module.
Data from the OneView system
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Duration of the hospital stay, an average of 3 days
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Repeated Engagement with the Education Module
大体时间：Duration of the hospital stay, an average of 3 days
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Number of views of the educational module for participants who viewed it at least once
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Duration of the hospital stay, an average of 3 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Naomi S. Bardach, MD, MAS、University of California, San Francisco
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085. Erratum In: J Med Internet Res. 2015;17(2):e32. J Med Internet Res. 2015;17(2):e32.
- Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
- Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
- Alegria M, Polo A, Gao S, Santana L, Rothstein D, Jimenez A, Hunter ML, Mendieta F, Oddo V, Normand SL. Evaluation of a patient activation and empowerment intervention in mental health care. Med Care. 2008 Mar;46(3):247-56. doi: 10.1097/MLR.0b013e318158af52.
- Pennarola BW, Rodday AM, Mayer DK, Ratichek SJ, Davies SM, Syrjala KL, Patel S, Bingen K, Kupst MJ, Schwartz L, Guinan EC, Hibbard JH, Parsons SK; HSCT-CHESS Study. Factors associated with parental activation in pediatric hematopoietic stem cell transplant. Med Care Res Rev. 2012 Apr;69(2):194-214. doi: 10.1177/1077558711431460. Epub 2011 Dec 26.
- Deen D, Lu WH, Rothstein D, Santana L, Gold MR. Asking questions: the effect of a brief intervention in community health centers on patient activation. Patient Educ Couns. 2011 Aug;84(2):257-60. doi: 10.1016/j.pec.2010.07.026. Epub 2010 Aug 25.
- Smith MY, Winkel G, Egert J, Diaz-Wionczek M, DuHamel KN. Patient-physician communication in the context of persistent pain: validation of a modified version of the patients' Perceived Involvement in Care Scale. J Pain Symptom Manage. 2006 Jul;32(1):71-81. doi: 10.1016/j.jpainsymman.2006.01.007.
- Alegria M, Sribney W, Perez D, Laderman M, Keefe K. The role of patient activation on patient-provider communication and quality of care for US and foreign born Latino patients. J Gen Intern Med. 2009 Nov;24 Suppl 3(Suppl 3):534-41. doi: 10.1007/s11606-009-1074-x.
- Bardach NS, Lam R, Jasik CB. Assessment of automated clinical trial recruitment and enrolment using patient-facing technology. BMJ Health Care Inform. 2021 Jan;28(1):e100076. doi: 10.1136/bmjhci-2019-100076.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年8月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年3月1日
研究注册日期
首次提交
2015年6月26日
首先提交符合 QC 标准的
2015年7月6日
首次发布 (估计)
2015年7月7日
研究记录更新
最后更新发布 (估计)
2016年5月16日
上次提交的符合 QC 标准的更新
2016年5月12日
最后验证
2016年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 15-16151
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不
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